Method of manufacturing a guidewire with an extrusion jacket

ABSTRACT

A method of manufacturing a guidewire having a discrete length. The method includes the steps of feeding a first end of a corewire into an extrusion device, gripping the first end of the corewire with a gripping apparatus, and extruding a first extrusion material onto an outer surface of the corewire while the gripping apparatus pulls the corewire through the extrusion device to form an extrusion jacket on the outer surface of the corewire. The corewire has a predetermined length corresponding to a length of the guidewire.

CROSS-REFERENCED TO RELATED APPLICATIONS

This is a continuation of application Ser. No. 11/826,766, filed Jul.18, 2007, which is a continuation of application Ser. No. 10/431,378,filed May 8, 2003, now U.S. Pat. No. 7,670,526 issued Mar. 2, 2010,which is a continuation of application Ser. No. 10/376,324, filed Mar.3, 2003, now U.S. Pat. No. 7,241,406 issued Jul. 10, 2007, which is adivision of application Ser. No. 09/749,381, now U.S. Pat. No. 6,554,942issued Apr. 29, 2003, all of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a method of manufacturing a guidewire with anextrusion jacket, and more particularly, to a method of manufacturing adiscrete length guidewire of varying thickness. The invention alsorelates to a method of manufacturing a discrete length guidewire with ahelical stripe on the extrusion jacket.

2. Description of the Related Art

Medical guidewires are generally used for navigating through internalpassageways of a body. A typical guidewire includes a corewire having aproximal shaft of constant diameter and a taper section of progressivelynarrowing diameter leading to a distal tip. In order to prevent damageto the body, the guidewire typically includes a relatively soft plasticjacket on the outer surface. The distal end of a guidewire is introducedinto a body by a physician through an opening in the body. The physicianmanipulates the tip of the guidewire through the body to a site to betreated. A catheter or other medical device is usually advanced over theguidewire to the treatment site, and the guidewire is then removed.

Current methods of manufacturing a guidewire with an extrusion jackethave certain drawbacks. Current methods utilize a continuous spool ofcorewire during the tapering of sections into the corewire, as well asduring the extrusion of a plastic jacket onto the corewire. The use of acontinuous spool of corewire during tapering and for extruding a jacketonto the corewire is complex and cumbersome. It is difficult to grind acontinuous spool of corewire with a varying tapered diameter.

One method of producing a spool of continuous corewires involves the useof acid to etch a taper onto the corewire. The etching method, however,raises environmental concerns. Therefore, for the above reasons, thecurrent methods for manufacturing a continuous tapered corewire are lessthan desirable.

After the continuous spool of corewire is manufactured and ground, aplastic jacket is typically applied to the outside surface of thecorewire. The current methods utilized in applying a plastic jacket to acontinuous spool of corewire have certain drawbacks. A typical method ofjacketing a continuous corewire also uses a pay-off spool and take-upspool. In this method, the corewire unwinds from a pay-off spool and isthen led through a crosshead with a jacket extruder. As the corewirepasses through the crosshead, a jacket is extruded onto the corewire.The jacket is then cooled, and the wire is either respooled onto atake-up spool or cut to a predetermined length. After the corewire iscooled, therefore, additional steps, such as cutting the corewire to alength, are required in order to obtain a usable discrete lengthguidewire. There is a need therefore for a method of extruding a jacketon a corewire which substantially obviates these drawbacks.

Some jackets of conventional guidewires include a helical stripe to makeit easier for a surgeon to see that the guidewire is beinglongitudinally displaced in the opening of the human body. The currentmethod for applying a jacket having a helical stripe to a corewire alsohas certain drawbacks. In order to obtain a guidewire with a helicalstripe, a heat shrinkable hollow tube is used. The heat shrinkabletubing is manufactured by extruding a longitudinal stripe on the hollowtube and then heating, twisting, and cooling the hollow tube. This heatshrinkable tubing can then be heat shrunk onto a corewire to form thejacket of the corewire. This process of heat shrinking the tubing on acorewire, however, does not provide a very strong connection between thejacket and the corewire. Therefore, this can result in a guidewire inwhich undesired movement occurs between the corewire and the jacket.Moreover, only a limited number of materials are suitable for heatshrinkable tubing, thereby limiting the type of materials that can beused for the jacket. There is a need therefore for a method ofmanufacturing a guidewire with a jacket having a helical stripe whichsubstantially obviates these problems.

SUMMARY OF THE INVENTION

The advantages and purposes of the invention will be set forth in partin the description which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. Theadvantages and purposes of the invention will be realized and attainedby means of the elements and combinations particularly pointed out inthe appended claims.

To attain the advantages and in accordance with the purposes of theinvention, as embodied and broadly described herein, the inventionincludes a method of manufacturing a guidewire having a discrete length.The method includes the steps of: feeding a first end of a corewire intoan extrusion device; gripping the first end of the corewire with agripping apparatus; and extruding a first extrusion material onto anouter surface of the corewire while the gripping apparatus pulls thecorewire through the extrusion device to form an extrusion jacket on theouter surface of the corewire. The corewire has a predetermined lengthcorresponding to a length of the guidewire

In another aspect, the invention includes the above method and theadditional step of extruding a visually distinct second extrusionmaterial on the jacket of the corewire while the gripping apparatuspulls the corewire through the extrusion device. During the step ofextruding the second extrusion material, the above method furtherincludes the step of rotating the gripping apparatus to rotate thecorewire so that the second extrusion material forms a helical stripe onthe jacket of the corewire.

In a further aspect of the invention, the invention includes a corewireto be used in manufacturing a guidewire. The corewire includes: a firstend section of a substantially constant diameter; a tip section having adiameter less than the first end section diameter; and a second endsection of a substantially constant diameter, the second end sectiondiameter being greater than the diameter of the tip section.

In a yet further aspect of the invention, the invention includes anapparatus for manufacturing a discrete length guidewire having anextrusion jacket. The apparatus includes: a first extruder for supplyinga first extrusion material onto an outer surface of a corewire to forman extrusion jacket; and a gripping apparatus for gripping a portion ofthe corewire that has passed through the first extruder, the grippingapparatus being capable of imparting a motion on the corewire as thecorewire passes through the first extruder. The gripping apparatus iscapable of varied movement to change a physical characteristic of theextrusion jacket.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention. In the drawings,

FIG. 1 is a partial cross-sectional side view of an apparatus formanufacturing a discrete length guidewire according to an embodiment ofthe invention, prior to insertion of a corewire into a crosshead;

FIG. 2 is a partial cross-sectional side view of the apparatus of FIG.1, with a gripping apparatus gripping onto an extruded corewire;

FIG. 3 is a partial cross-sectional side view of the apparatus of FIG.1, prior to removal of the corewire from the crosshead;

FIG. 4 is a partial cross-sectional side view of the apparatus of FIG.1, after removal of the corewire from the crosshead;

FIGS. 5-6 are partial cross-sectional side views of the apparatus ofFIG. 1, showing an extruded corewire that resulted from varying thelinear speed of the gripping apparatus according to an embodiment of theinvention;

FIG. 7 is a cross-sectional side view of the crosshead of the apparatusof FIG. 1 and a corewire therein according to an embodiment of theinvention;

FIGS. 8-9 are corewires according to an embodiment of the invention;

FIG. 10 is a cross-sectional side view of the crosshead of FIG. 7 with aguiding tube according to an embodiment of the invention;

FIG. 11 is a schematic side view of an apparatus for manufacturing adiscrete length guidewire according to an embodiment of the inventionwith a conveyor system;

FIG. 12 is a partial cross-sectional side view of an apparatus formanufacturing a discrete length guidewire with a helical stripeaccording to an embodiment of the invention, prior to insertion of acorewire into a crosshead;

FIG. 13 is a partial cross-sectional side view of the apparatus of FIG.12, with a rotating gripping apparatus gripping onto an extrudedcorewire;

FIG. 14 is a partial cross-sectional side view of the apparatus of FIG.12, prior to removal of the corewire from the crosshead; and

FIG. 15 is a partial cross-sectional side view of the apparatus of FIG.12, after removal of the corewire from the crosshead.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to the present preferredembodiments of the invention, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.

In accordance with the present invention, a method for manufacturingguidewires, and particularly discrete length guidewires, is provided.The method for manufacturing discrete length guidewires typicallyincludes feeding a first end of a corewire into an extrusion device;pulling the corewire through the extrusion device, and extruding anextrusion material onto an outer surface of the corewire. In aparticular preferred embodiment, a gripping apparatus grips the firstend of the corewire and pulls the corewire through the extrusion deviceto form an extrusion jacket on the outer surface of the corewire.

An apparatus 10 for performing the method of manufacturing, as embodiedherein and shown in FIGS. 1-7, includes an extrusion device including anextruder 12, an adapter 14, and a crosshead 16. The extruder 12 can beany known device for providing an extrusion material 30 to an adapter. Atypical extruder includes an extrusion screw 13 and barrel 15 as shownin FIGS. 1-6. The screw 13 is located inside the cylindrical barrel 15so that rotation of the screw 13 causes the extrusion material 30 toflow to the adapter 14.

The adapter 14 is in the shape of a funnel to provide the extrusionmaterial 30 to the crosshead 16 from the extruder 12. Crosshead 16includes a cylindrical outer portion 18 and an inner portion or die 20.As best shown in FIG. 7, the cylindrical outer portion 18 includes asupply port 22 for receiving extrusion material 30. The extrusionmaterial 30 travels from the supply port 22 to a circumferential groove24 in a flow diverter portion 26 of the crosshead. The circumferentialgroove 24 extends around the outer circumference of the flow diverter 26as shown in FIG. 7. The extrusion material 30 then flows through aconical space 28 between the flow diverter 26, tip 34, and die 20 of thecrosshead, as best shown in FIG. 7. The extrusion material is thenapplied to the outside diameter of a discrete length corewire 40 atextrusion material supply opening 32, as will be described in greaterdetail below.

The die 20 of the extruder 16 further includes a tapered opening 34 forentrance of the corewire. The tapered opening 34 has a conical innersurface that leads to a cylindrical inner surface defining a hole 36.The cylindrical inner surface defining hole 36 guides the corewirethrough the crosshead.

According to an embodiment of the present invention, the method formanufacturing a discrete length guidewire will be described withreference to FIGS. 1-6. FIG. 1 shows the extrusion apparatus 10 andcorewire 40 prior to insertion of the corewire into the crosshead 16.Corewire 40 is shown as being a constant diameter corewire. A preferablecorewire, however, is the corewire shown in FIG. 7-9. Details of thepreferred shape of that corewire will be discussed below. Any shapecorewire, however, may be used in the extrusion methods and apparatus ofthe present invention. The discrete length corewire is typically groundinto the desired shape by the use of a centerless grinding techniqueknown in the art or any other suitable method.

Prior to and during extrusion, a predetermined amount of extrusionmaterial 30 is allowed to flow through the extrusion device. Control ofthe amount of material 30 may be performed by any suitable controlapparatus or method known in the art. Preferably, the extrusion deviceis controlled by computer controls with an interface control panel. Thedesired flow speed of the extrusion material is a function of a varietyof factors such as the rotational speed of the extrusion screw 13, thetemperature of the extrusion material, the properties of the particularextrusion material, and the tooling design.

Once the extrusion material begins to flow, the first end of corewire 40is fed into the extrusion device at the tapered opening 34 of thecrosshead 16 and then into the hole 36 of the crosshead 16. Theguidewire may be manually fed into the crosshead by an operator orautomatically fed into the extrusion device by an automatic payoffsystem. Once the first end of the corewire 40 reaches the extrusionmaterial supply opening 32, the extrusion material 30 adheres to theoutside surface of the corewire 40. The extrusion material 30 forms anextrusion jacket 38 on the outer surface of the corewire, as best shownin FIG. 7. The jacket 38 is preferably concentric with the central axisof the corewire. The extrusion material can be any of the knownmaterials suitable for extrusion and insertion into the human body, suchas, but not limited to, polyurethane, polyethylene, nylon, pebax, andpolycarbonate. The extrusion material may also include additives thatare appropriate for the specific intended use of the guidewire. Forexample, fillers such as tungsten, barium sulfate, bismuth trioxide, andbismuth subcarbonate are often added for radiopacity. Other fillers maybe used in order to increase characteristics such as surface friction,density, and lubricity.

It is desirable for the extrusion material to closely adhere to theoutside surface of the corewire so that the extrusion jacket 38 cannoteasily come off of the corewire. There are several methods forincreasing the adhesion between the extrusion jacket and the corewire.In a first method, a polymer is added to the extrusion jacket materialin order to increase the adhesion between the extrusion jacket andcorewire. In a second method, the corewire is coated with silane priorto insertion into the crosshead. The silane promotes adhesion betweenoxides formed on the corewire and the extrusion material. Other methodsof increasing the adhesion between the extrusion jacket and corewire mayalso be used.

After the first end of the corewire 40 passes through the crosshead andthe jacket 38 begins to extrude onto its outer surface, a grippingapparatus 50 clamps onto the jacket 38 at the first end of the corewire,as shown in FIG. 2. The gripping apparatus 50 may be a pneumaticgripper, however any other suitable gripping apparatus is alsoacceptable. The gripper is mounted on a carriage (not shown) whichtraverses along a linear rail (not shown). The motion of the carriagemay be controlled by a stepper or servo motor, or any other suitablemeans to control the carriage motion.

The guidewire can be pulled through the crosshead 16 by the grippingapparatus 50 at a variety of speeds. The effect of a variation inguidewire speed will be discussed further. The controller also controlsthe travel distance of the gripping apparatus 50. As the grippingapparatus 50 is translated to the right in FIG. 3, the extrusion jacket38 is extruded onto the outer surface of the corewire.

As the corewire 40 with extruded jacket 38 is translated to the right inFIG. 3, the entire corewire 40 is pulled through the crosshead 16. Thejacket and corewire then may be placed in and pulled through a coolingtrough by the gripping apparatus. Cooling troughs are well known in theart, therefore details of the cooling trough are not shown. After theentire corewire with the extruded jacket has passed through the coolingtrough, the guidewire is released by the gripping apparatus, as shown inFIG. 4, and placed into a holding tray (not shown). The cycle is thenrepeated for subsequent corewires to manufacture additional guidewires.Alternate methods of translating corewires through the crosshead will bedescribed later.

A variation in the speed of the corewire passing through the crossheadwill vary the thickness of the jacket along the guidewire length. FIG. 5shows an example of the results of varying the linear speed of thecorewire through the crosshead. In FIG. 5, the corewire was initiallypulled through the crosshead at a constant speed. Therefore, thethickness of the jacket is constant in the initial section of thecorewire, i.e., the section to the right in FIG. 5. Thereafter, thespeed of the gripping apparatus motion was increased to increase thespeed of the corewire through the crosshead. The increase in linearcorewire speed resulted in a smaller thickness extrusion jacket.Therefore, the diameter at the second end portion of the guidewire,i.e., the portion to the left in FIG. 5, is smaller than the diameter atthe first end of the guidewire. The result of such a variation incorewire speed is shown in FIG. 6. In this case, the gripping apparatus(and therefore the corewire) was displaced at a substantially constantacceleration, resulting in the outside diameter of the guidewire jackethaving a smooth taper. The speed of the gripping apparatus and thereforethe speed of the corewire through the crosshead may be changed at anyrate to result in a guidewire having a desired shape. For example, aconstant diameter corewire may be used to form a guidewire with atapered section leading to a distal tip, as shown in FIGS. 5 and 6.

The corewire of a guidewire can consist of a variety of shapes, and acorewire of any such shape can be used in the extrusion process of thepresent invention. For example, a corewire for use in the methodsaccording to the present invention is shown in FIGS. 7-9. The corewire40 has a number of regions with different diameter profiles. Thecorewire 40 includes a main shaft section or first end section 42 ofsubstantially constant diameter. The end referred to as the first endsection 42 is the portion of the corewire which is initially insertedinto the crosshead. As shown in FIGS. 8-9, first end section 42 ofconstant diameter extends to a tapered section 44. The beginning oftapered section 44 has an outer diameter equal to the outside diameterof the first end section 42. The diameter of the taper portion 44decreases until it reaches the diameter of a tip section 46. The tipsection 46 has a substantially constant diameter, preferably of asmaller diameter than the first end section 42. The tip section 46preferably tapers to a second end section or paddle section 48 of asubstantially constant diameter. The diameter of second end section 48is preferably greater than the diameter of the tip section 46, forreasons which will be discussed below.

The paddle section 48 enables the crosshead to apply a concentric jacketof extrusion material on the tip section 46 of the corewire. As shown inFIG. 7, the diameter of the tip section 46 of the guidewire issubstantially smaller than the diameter of hole 36 defined by the innercylindrical surface of the crosshead. Therefore, there is a gap betweenthe outside surface of the corewire 40 and the inner cylindrical surfaceof hole 36. This gap is filled with extrusion material as shown in FIG.7. It is desirable that the extrusion material be applied evenly aroundthe corewire, including the tip section 46. Therefore, it is desirableto have a centering system which centers the tip section 46 in thecrosshead in order to provide a uniform jacket 38 around the tip section46. The paddle section 48 serves as the centering system once the paddlesection enters hole 36 as shown in FIG. 7. The diameter of paddlesection 48 is only slightly smaller than the inner diameter of hole 36.Therefore, because the tip section 46 is concentric with the paddlesection 48, the tip section 46 will be centered in the inner cylindricalsurface 36 of the crosshead and the jacket applied to the tip section 46will also be concentric.

The paddle section 48 will serve the function of centering the tipsection even if the corewire has been bent. It is often desirable to usean angled tip corewire in order to better manipulate through the humanbody. For certain operations, it is best to have a predetermined bend onthe corewire tip prior to insertion into the human body. However,because of the properties of the corewire material, it is oftennecessary to heat the corewire to high temperatures in order to bend thecorewire to the desired angle. For example, linear elastic materialssuch as nickel titanium alloy have linear-elastic characteristics whichrequire heating in order to bend the tip of the corewire into an angledor J shape. Other suitable materials include, but are not limited to,super-elastic materials, stainless steel, titanium, and compositecorewires of fiberglass or carbon-fiber. Therefore, the corewire that isto be inserted into the crosshead may have a predetermined bend in it,as shown for example in FIG. 9 where tip section 46 has a bend. Thepaddle section 48 allows the crosshead to apply a concentric extrusionjacket on the corewire, even though the corewire has a significant bendin it.

Even with a significant bend in the corewire 40, the corewire 40 willbegin to straighten as it is translated through the crosshead 16. As thetip section 46 first enters hole 36 of the crosshead 16, the bend in thetip section 46 will cause the tip section 46 to be off-center from thecenter of hole 36. However, as the corewire 40 is pulled through thecrosshead 16, the paddle section 48 will abut the tapered opening 34 ofthe crosshead and begin to straighten the corewire 40. As the corewire40 is further drawn through the crosshead 16, the beginning of thepaddle section 48 will enter hole 36 of the crosshead 16, straighteningthe corewire 40 and centering the tip section 46, as shown in FIG. 7.The tip section 46 will now receive a concentric extrusion jacket 38 asit passes through the crosshead 46. After the tip section 46 and thepaddle section 48 have completely exited the crosshead 16, the corewire40 may regain some or all of its previous bend, depending, for example,on the properties of the corewire and extrusion materials and the amountof bend. Alternately, also depending on the materials and the amount ofbend, the corewire may remain straight.

The provision of a paddle section on the corewire is particularly usefulwhen extruding an extrusion jacket on a corewire having an angled tip.The paddle section assists in centering the corewire in the crossheadhole so that the extrusion jacket will be concentric with the corewire.The provision of the paddle section may also be helpful in improvingcentering in a substantially straight corewire that has minor bends. Itmay be possible, however, to have a completely straight corewire thatrequires no paddle section for centering. In such a corewire without apaddle section, the distalmost end of the corewire will be the tipsection.

In an alternate embodiment of the present invention, the crosshead mayinclude a guiding member for centering the core wire in the crosshead.As embodied herein and shown in FIG. 10, a guiding member in the shapeof a guiding tube 49 is located adjacent the opening of crosshead 16 andreceives corewire 40. The remainder of the crosshead and the corewireare identical to the crosshead and corewire illustrated in theembodiment shown in FIGS. 7-9. The guiding tube 49 has a cylindricalopening 51 that is coaxial with hole 36 of the crosshead 16. The coaxialrelationship between the guiding tube 49 and the hole 36 will ensurethat the shaft section 42 of the corewire 40 will initially be insertedin the crosshead in a coaxial manner, in addition to the ensuring thatthe corewire will remain centered in the crosshead throughout theextrusion process. The first end section 42 of the corewire 40 initiallyis inserted through the guiding tube, then hole 36 of the crosshead. Asthe corewire 40 is pulled through the crosshead, the bent portion of thetip section 46 will enter into the cylindrical opening 51 of the guidingtube 49. The bent portion of the tip section 46 will abut against theinner surface of the cylindrical opening 51 of the guiding tube 49 andstraighten the corewire 40. In this manner, the straightened corewirewill be fed through the crosshead 16. The guiding member is not limitedto being a tube 49, but may be any other suitable size and shape thatcenters the corewire in the crosshead.

To complete the manufacture of the guidewire, after the corewire withjacket is pulled through the cooling trough and placed in a holdingtray, as previously described, the paddle section 48 is removed, leavingtip section 46 as the distalmost portion of the final guidewire. Afterthe paddle section is removed, it is desirable that the distalmostportion of the tip section of the final guidewire be provided with aclosed tip formed of polymeric or resin-like material similar oridentical to the extrusion material. The provision of such a tip reducesthe likelihood of damage to the body which would occur if the metalcorewire was exposed. There a variety of methods of providing anextrusion-like material to the distalmost portion of the final guidewireafter the paddle section has been removed. In a first method, theguidewire is heated and a tip is molded onto the distalmost portion ofthe guidewire. The molded tip can be made out of the same material asthe extrusion jacket, or out of a different material. In a secondmethod, a tip is heat formed onto the distalmost portion of theguidewire from the existing extrusion material of the jacket. When theguidewire is heated, the extrusion material of the extrusion jacket willflow towards the distal end of the guidewire to form a tip. A thirdpossible method is to dip the distalmost end of the guidewire into aglue or resin solution. The glue or resin will then bond to theextrusion material and tip of the corewire to form a smooth tip. In thethird method, the material in which the guidewire is dipped could alsobe made out of the extrusion material. In a fourth method of providingan extrusion-like material to the distalmost end of the tip section, theextrusion material is recessed back from the distalmost end of thecorewire before or as the paddle section is cut off. Therefore, afterthe paddle section is cut off, the resulting guidewire has thedistalmost end slightly recessed in the extrusion material jacket. Theextrusion material jacket projects beyond the end of the corewire. Thetip of the guidewire can then be heated so that the projecting extrusionjacket melts around the distalmost end of the corewire to form a tip ofthe extrusion material.

It may also be desirable to remove a portion of the proximalmost tip ofthe guidewire. In such a case, it is desirable to provide a closed tipformed of polymeric or resin-like material using any of the methodsdescribed above for the distalmost portion.

The above method is described as using a single gripper to pull theguidewire through the crosshead. However, alternate methods oftranslating consecutive guidewires through the crosshead are alsoacceptable. In a first alternate method, a second gripper is provided inaddition to the first gripper. The first gripper will grip the firstguidewire as previously described. Once the first guidewire is pulledcompletely through the crosshead, a second guidewire will typicallyproject from the crosshead. At this point, since the first gripper isstill gripping the first guidewire, a pause in the linear translation oran additional axial spacing between the guidewires will be requiredbefore the first gripper can translate back to the crosshead and gripthe second guidewire. It is undesirable to have a long delay betweeneach guidewire being translated through the crosshead. The axial spacingis also undesirable because a large amount of extrusion material iswasted in the regions between the guidewires. The provision of a secondgripper helps to alleviate these problems. The second gripper can graspthe second guidewire immediately upon the second guidewire projectingthrough the crosshead. Therefore, consecutive guidewires can haveminimal spacing therebetween, and there is no need for a pause betweeninsertion of guidewires.

In a method according to another embodiment of the present invention, aconveyor system translates the guidewires through the crosshead, asopposed to the grippers described in the above embodiment. FIG. 11illustrates one example of a conveyor system that can be used with thepresent invention. The conveyor system 300 preferably is locateddownstream, i.e., after the crosshead 16. The conveyor system preferablyincludes a puller comprising at least one belt-like conveyor, and may bedesigned to engage the bottom of the guidewire, or both the bottom andthe top of the guidewire. As shown in FIG. 11, the puller 310 includestwo belt-like conveyors 312 and 314 for engaging the top and bottom ofthe guidewire. In addition, a conventional water bath 320 is providedbetween the crosshead and conveyor system. The water bath cools theextrusion jacket after the corewire has left the crosshead. The waterbath is typically at least several feet long, the water bath lengthbeing a factor of the speed at which the guidewires are fed through thecrosshead, the temperature of the newly extruded extrusion material, andthe temperature of the cooling water in the water bath.

The initial step of the method employing the conveyor system and waterbath is to form a long strand of entirely extrusion material that willbe used to pull the initial guidewires through the crosshead and waterbath to the conveyor system. To form this long strand, extrusionmaterial is extruded into the hole in the crosshead without insertion ofa corewire. The initial extruded strand is then pulled through the waterbath and inserted between the conveyors 312 and 314 of the puller 310.The initial extruded strand is pulled through the water bath and intothe puller by any suitable means, such as the manual use of a pair ofpliers to grip the strand. Once the initial extruded strand issufficiently inserted into the puller, the puller pulls the long initialstrand of extrusion material through the crosshead and water bath.

The first corewire then is inserted into the crosshead via a payoffsystem or manual insertion, while extrusion material continues to flowinto the crosshead. FIG. 11 illustrates one example of payoff system 330for inserting the corewire into the crosshead. The corewire thereby hasan extrusion jacket 38 extruded on it as it passes through the crosshead16. The extrusion jacket is integrally connected to the long strand ofextrusion material so that the strand (through action of the conveyor)pulls the corewire through the crosshead, then through the water bath,until the corewire reaches the puller of the conveyor system. A secondcorewire is inserted into the crosshead, leaving a small amount of axialspace between the first and second corewires. Because extrusion materialcontinues to flow between consecutive corewires, a strand of extrusionmaterial 39 extends between consecutive guidewires, helping to pull theupstream guidewire through the crosshead. This results in a series ofconnected guidewires with a small amount of extrusion material 39located therebetween. The extrusion material located between theguidewires is later removed, along with the paddle section of theguidewires. The scope of the present invention includes other alternatemethods besides those described above to translate a corewire throughthe crosshead.

As illustrated in FIG. 11, the system may further include a detector 340for sensing the location of the guidewires. Detector 340 may be anysuitable detection device, such as a metal detector. The metal detector,in one embodiment, is located immediately downstream from the water bath320. A laser micrometer 342 may be located after the metal detector forsensing the dimensions and position of the guidewire. In one embodiment,the laser micrometer is located immediately before the puller 310. Thedetector and/or micrometer aid in the precise cutting of the guidewires,and particularly the extrusion material 39 between adjacent guidewires.A cutting device 344 may be included immediately after the puller 310for cutting the extrusion material 39 between adjacent guidewires.

Based on the speed of the puller and the position information from themetal detector and/or laser micrometer, a feedback control systemactivates the cutter at a predetermined time. This feedback controlsystem also utilizes information from the metal detector and lasermicrometer to control the outer diameter of the extrusion jacket of theguidewire by adjusting various factors such as the linear speed of thepuller or conveyor and/or the rotational speed of the extrusion screw13. The conveyor system shown in FIG. 11 also includes an additionalconveyor 346 located downstream from the pulley 310. After the extrusionmaterial between the guidewires is cut by cutting device 344, theguidewire is fed onto the additional conveyor 346 by the puller 310. Theconveyor 346 takes the guidewire with the extruded jacket from thepuller 310, and translates the guidewire to the next station. Asillustrated in FIG. 11, a control panel display 348 may be included inorder to display control information.

The above methods will produce a discrete length guidewire with aminimum number of steps and processes. Additionally, the discrete lengthguidewire can be manufactured with a predetermined bend. The abovemethods can also be used to manufacture a variety of medical devicesother than guidewires. For example, the above methods can be used toextrude material onto the coil of a biopsy device, catheter, stent,snare, or other endoscopic device. The above methods are acceptable forextruding material onto any suitable longitudinal medical device, and isnot limited to the examples described above.

Another embodiment of the invention will now be described wherein likeor similar parts are identified throughout the drawings by the samereference numerals. This embodiment is directed toward a method formanufacturing a discrete length guidewire with a jacket having a helicalstripe. In accordance with this embodiment of the present invention, amethod of manufacturing a discrete length guidewire includes extruding ajacket similar to that described above, but further includes theextrusion of a second extrusion material to form a helical stripe on thecorewire. Embodiments of the method and apparatus for practicing themethod now will be described.

As embodied herein and shown in FIGS. 12-15, the apparatus 110manufactures a discrete length guidewire with a jacket having a helicalstripe. Apparatus 110 includes a first extruder 112 and a first adapter114. The first extruder 112 and first adapter 114 are substantiallyidentical to the extruder 12 and adapter 14 described above. Thecrosshead 116 is different than the crosshead 16 described above becausecrosshead 116 extrudes both a first extrusion material 130 to form thejacket and a second extrusion material 230 to form the jacket stripe.Although the structure of crosshead 116 for extruding the firstextrusion material is substantially the same as the structure ofcrosshead 16, crosshead 116 further includes structure for extruding asecond extrusion material to form a stripe. The crosshead 116 allows fora second extruder 212 and a second adapter 214 that contain a secondextrusion material 230.

In a preferred embodiment, the second extrusion material 230 is visuallydistinct from the first extrusion material 130. The second extrusionmaterial is different in color, shade, or otherwise different inappearance, than the first extrusion material. The second extrusionmaterial, however, can be made of the same materials as the firstextrusion material, or different materials. The first and secondextrusion materials are preferably formed of any of the extrusionmaterials described above. The first and second extrusion materials mayalso be provided with the fillers described above. For example, it isoften desirable to make the second extrusion material out of materialhaving a different radiopacity than the first material.

The second extrusion material 230 flows from the second extruder 212 tothe second adapter 214. The end of the second adapter 214 has a thinexit port 216 that leads to a second extrusion material port 218 in thecrosshead, as shown in FIG. 12. The second extrusion material port 218is located on the inner surface of the crosshead at the conical groove128. The second extrusion material 230 is applied to the exterior of thefirst extrusion material 130. The applied amount of second extrusionmaterial is preferably substantially less than the applied amount offirst extrusion material because often only a thin stripe is desired onthe outside of the first extrusion material. The amount of secondextrusion material applied over the first extrusion material may vary,however, according to the desired thickness of the helical stripe. Aswith the first extrusion material, control of the applied amount ofsecond extrusion material may be performed by any suitable controlapparatus or method known in the art.

The method for creating the jacket and stripe on the jacket will bedescribed in connection with FIGS. 12-15. FIG. 12 shows the apparatus110 prior to insertion of the first end section of the corewire 40 intothe crosshead 116. The corewire 40 can be any type of corewire,including the tapered corewire described above and shown in FIGS. 8-9.The first end section of the corewire 40 is fed into the crosshead 116.As the corewire 40 passes by the conical groove 128, the first extrusionmaterial 130 begins to form a jacket on the outside surface of thecorewire 40. As the first extrusion material 130 is extruded onto theoutside surface of the corewire, the second extrusion material 230 isdispensed onto the outside surface of the first extrusion material 130.

In order to provide rotation (to obtain a helical shape) and translationto the corewire 40, a rotating gripper 150 with clamps 152 is provided.The rotating gripper 150 clamps on the outside surface of the jacketafter the first end of the corewire exits the crosshead. The rotatinggripper 150 proceeds to rotate and linearly translate upon gripping thecorewire with jacket.

The rotating gripper 150 is attached to a carriage (not shown) thattraverses along a linear rail (not shown) and rotates about the axis ofthe corewire. Alternately, any other suitable method of rotating andlinearly translating the guidewire is also acceptable. The motion of thecarriage and gripper may be controlled by a stepper or servo motor, orany other suitable means. The rotational and linear motion of thegripper causes the second extrusion material to form a helical stripe232 on the outside of the guidewire, as shown in FIGS. 13-15. With aconstant rotational and linear speed, the helical stripe 232 will have aconstant pitch.

The method also preferably includes varying the linear and/or rotationalspeed of the rotating gripper to create a stripe with a varying helicalpitch. For example, if the rotational speed of the gripper is decreased,the pitch of the stripe (distance between the threads of a helicalstripe) will increase. FIGS. 14 and 15 show a guidewire created withdecreasing rotation speed to create an increasing pitch on the stripe232. As shown in FIGS. 14 and 15, the pitch of the stripe 232 increasesfrom the first end section to the second end of the guidewire. Thelinear speed of the gripper can also be varied. A variation in thelinear speed of the gripper and corewire passing through the crossheadwill have the same effect as discussed in connection with FIGS. 5 and 6.An increase in the linear speed of the corewire will cause the thicknessof the jacket to decrease. In addition, an increase in the linear speedof the corewire will also cause the pitch of the stripe 232 to increase,resulting in greater spacing between adjacent stripes.

The provision of a helical stripe with a variable pitch is useful in theprocess of inserting or removing a guidewire into and out of the humanbody. The stripe allows for visual confirmation that the guidewire isbeing longitudinally displaced. By varying the helical pitch of thestripe along the length of the guidewire, an operator can visuallydetermine the depth of the guidewire. Because the proximal end mighthave a low pitch, while the distal end has a high pitch, it is possibleto estimate how far the guidewire has been inserted.

The remainder of the manufacturing method corresponding to theembodiment of FIGS. 12-15 is substantially identical to the methoddescribed above. The corewire with the jacket is pulled through acooling trough (not shown). The completed guidewire is released by thegripper and placed in a holding tray (not shown). The cycle is thenrepeated for the next corewire. A number of discrete length guidewireshaving a variable pitch helical stripe can thus be manufactured.

In an alternate method of manufacturing a discrete length guidewire witha jacket having a helical stripe, the crosshead 116 rotates instead ofthe gripper 150. In such a configuration, the relative rotation of thecrosshead relative to the corewire causes a helical stripe to be formedin the extrusion jacket.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the apparatus and method ofmanufacturing a discrete length guidewire, use of the apparatus of thepresent invention, and in construction of this apparatus, withoutdeparting from the scope or spirit of the invention.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

What is claimed is:
 1. A method of manufacturing a guidewire,comprising: feeding a first end of a core wire into an extrusion device,the core wire comprising: a first end section having a first diameter; asecond end section having a second diameter opposite the first endsection; and a tip section having a third diameter disposed between thefirst end section and the second end section; a tapered section disposedbetween the first end section and the tip section; wherein the seconddiameter is greater than or equal to the first diameter and the thirddiameter is less than the first diameter; and wherein the second endsection is detachably connected to a distal end of the tip section;translating the core wire through the extrusion device; extruding anextrusion jacket comprising extrusion material onto an outer surface ofthe core wire as the core wire is translated through the extrusiondevice; removing the second end section from the core wire to define thedistal end of the tip section having the third diameter as a distal tipof the guidewire.
 2. The method of claim 1, further comprising: afterremoving the second end section from the core wire, encapsulating thedistal end of the tip section.
 3. The method of claim 2, whereinencapsulating the distal end of the tip section includes heating thedistal tip.
 4. The method of claim 3, wherein heating the distal tipmakes the extrusion jacket flow toward the distal tip and encapsulatethe distal end of the tip section.
 5. The method of claim 3, whereinbefore removing the second end section, the extrusion jacket is pulledback from the distal end of the tip section toward the first end.
 6. Themethod of claim 5, wherein after removing the second end section andbefore heating the distal tip, the distal end of the tip section isrecessed within the extrusion jacket.
 7. The method of claim 2, whereinencapsulating the distal end of the tip section includes molding aseparate tip member onto the distal end of the tip section.
 8. Themethod of claim 2, wherein encapsulating the distal end of the tipsection includes dipping the distal tip into a glue or resin solution toform a smooth tip.
 9. The method of claim 1, wherein translating thecore wire through the extrusion device includes: translating at least aportion of the first end section at a first linear speed; and thereaftersubjecting the core wire to a substantially constant acceleration;wherein the substantially constant acceleration provides the extrusionjacket with smooth taper from a first outer diameter to a second outerdiameter smaller than the first outer diameter.
 10. The method of claim1, wherein an outer diameter of the tip section is less than an outerdiameter of the first end section.
 11. The method of claim 1, whereinthe tip section includes a predetermined bend such that the distal tipis angled.
 12. The method of claim 1, wherein the tip section includes apredetermined bend such that the distal tip is J-shaped.
 13. The methodof claim 1, further comprising: removing a proximalmost portion of thefirst end of the core wire.
 14. The method of claim 13, furthercomprising: after removing the proximalmost portion of the first end ofthe core wire, encapsulating the first end of the core wire.
 15. Themethod of claim 1, wherein before feeding the first end of the core wireinto the extrusion device, flowing extrusion material through theextrusion device.
 16. The method of claim 1, wherein before feeding thefirst end of the core wire into the extrusion device, the core wire iscoated with silane.